Pre-Emptive Chronic Obstructive Pulmonary Disease Risk Notifications Based on Medicament Device Monitoring

ABSTRACT

A system and method for providing chronic obstructive pulmonary disease (COPD) exacerbation risk notifications in real time or near-real time is described. Rescue and controller medication events are detected by sensors associated with the patient&#39;s medicament device/s, and provide a basis to determine to rescue and controller medication use trends for the patient. This data is analyzed to determine the patient&#39;s risk for COPD exacerbation after each event, and is used to send notifications to one or both of the patient and their health care provider.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of co-pending U.S. patent applicationSer. No. 15/293,851, filed on Oct. 14, 2016, which claims the benefit ofU.S. Provisional Application No. 62/242,095, filed Oct. 15, 2015, bothof which are incorporated by reference herein in their entirety for allpurposes.

BACKGROUND Field of Art

The disclosure relates generally to inhalers, and more specifically tomonitoring medicament device usage in relation to chronic obstructivepulmonary disease (COPD).

Description of the Related Art

Chronic obstructive pulmonary disease (COPD) is a significant and costlypublic health problem. Recent studies by the Centers for Disease Controland Prevention have listed COPD as the third leading cause of death inthe United States while estimating close to 13 million people may haveCOPD induced impaired lung function. Despite the development of newmedications, rates of hospitalizations and emergency room visits are notdecreasing; each year in the United States the disease causesapproximately 715,000 hospitalizations, and 134,000 deaths.Additionally, the cost to the nation for COPD was recently projected tobe approximately $49.9 billion, including $29.5 billion in direct healthcare expenditures, $8.0 billion in indirect morbidity costs and $12.4billion in indirect mortality costs.

Nearly all persons with COPD carry an inhaled medication to immediatelyrelieve symptoms whenever or wherever they occur. The frequency andlocation with which patients use these medications are importantindicators of how well the disease is controlled and treated. TheCenters for Disease Control and Prevention has recommended that temporaland geographic specificity of COPD surveillance data be monitored toimprove COPD treatment. Currently, healthcare providers are limited to aretrospective analysis of small proportions of attacks that led toemergency room visits and hospitalizations (i.e. the most severeexacerbations). These in-patient visits may indicate where the patientlives or the location of the health facility where they receivedtreatment, but provide no precise information about when or where theirexacerbation began.

Additionally, recently revised national guidelines urge doctors to moreclosely monitor whether prescribed treatment is controlling everydaysymptoms and improving quality of life. Healthcare providers, however,are limited by an availability of tools to assess how well theirpatients are doing on a day-to-day basis. An increasing number ofphysicians have begun to use periodic, written questionnaires (e.g. theCOPD Assessment Test (CAT)) to monitor patients and determine theirlevel of control. These instruments require patients to accuratelyrecall and report the frequency of symptoms, medicament device (e.g.inhaler) usage, and activity level and restriction over some period oftime, usually two to four weeks. As a result, collected informationrelating to COPD management has been subject to error introduced bybiases (e.g. fallible recollection), different interpretations ofsymptoms, and behaviors (e.g. non-adherence), and extremely limitedfrequency of data collection such that the data is of limited utility.

SUMMARY

A COPD analytics system is a unified platform for treating, monitoring,and managing exacerbations resulting from COPD. The COPD analyticssystem receives COPD rescue medication events by receiving notificationsfrom a sensor attached to a medicament device (e.g. inhaler) used by apatient who has authorized the COPD analytics system to help managetheir COPD. The sensor, when attached to or incorporated in a metereddose inhaler or other medicament device, records the geographicallocation, time, and date where and when a rescue medication event takesplace, and communicates that information to the COPD analytics system.The COPD analytics system analyzes the received events (both the mostrecent and previously received events) in real time or near-real time,and delivers timely information on the use of inhaled medications toinform and guide management of the disease, including alerts to patientsand the healthcare providers.

By providing timely information about the timing and frequency of theusage of the medication or medical device, and identifying thegeographic location where an individual uses their medication or medicaldevice, the COPD analytics system may help prevent COPD exacerbations bysuggesting immediately applicable changes of behavior, facilitate bettermanagement of a COPD treatment by the patient and their health careprovider, and improve recognition of specific locations (such asworkplace, school, or home, among others) that precipitate exacerbationsin order that the patient may avoid or modify these locations to preventfuture exacerbations.

The COPD analytics system is also able to aggregate the received eventdata anonymously across multiple patients to identify temporal andgeographic patterns of rescue medication events. As a result, the COPDanalytics system is able to provide healthcare providers andenvironmental health agencies with a real-time or near-real time way to(A) identify clusters of exacerbations, (B) assess the burden of diseasein a population or some portion of the population, and in somegeographic area, (C) plan and evaluate public health interventions toreduce morbidity, and (D) detect new epidemiological patterns or riskfactors.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows a COPD analytics system for monitoring accurate, real-timemedicament device usage, performing analytics on that data, andproviding COPD exacerbation risk notifications, according to oneembodiment.

FIG. 2 is a high-level block diagram illustrating an example of acomputing device used in either as a client device, application server,and/or database server, according to one embodiment.

FIG. 3A shows a dashboard of a client application that allows a user tointeract with a COPD analytics system, according to one embodiment.

FIGS. 3B-3R illustrate example cards displayed within the dashboard ofthe client application, according to one embodiment.

FIG. 4 shows an interaction diagram for providing COPD risk-basednotifications based on medicament device monitoring, according to oneembodiment.

FIG. 5 shows a flowchart for detecting a rescue medication event by aCOPD analytics system, according to one embodiment.

FIG. 6 shows a flowchart for providing a COPD risk analysis by a COPDanalytics system, according to one embodiment.

DETAILED DESCRIPTION I. System Environment

FIG. 1 shows a COPD analytics system 100 for monitoring accurate,real-time medicament device events, performing analytics on that data,and providing COPD exacerbation risk notifications, according to oneembodiment.

The COPD analytics system includes client computing devices 110, amedicament device sensor 120, a medicament device 160, an applicationserver 130, database server 140, and a network 150. Although FIG. 1illustrates only a single instance of most of the components of the COPDanalytics system 100, in practice more than one of each component may bepresent, and additional or fewer components may be used.

I.A. Client Device and Application

The client devices 110, at the behest of their users, interact with theCOPD analytics system 100 via the network 150. For purposes ofexplanation and clarity it is useful to identify at least two differenttypes of users. A patient 111 is a user burdened with COPD who makes useof the COPD analytics system 100 at least in part to obtain personalizedCOPD exacerbation risk notifications provided by the server 130 and COPDmanagement notifications created by their health care provider 112. Suchnotifications can be provided in exchange for the user's permission toallow the COPD analytics system 100 to monitor the patient's 111medicament device 160 usage. As will be explained below, medicationevents are detected by a sensor 120 associated with the medicamentdevice 160 and the user's client device 100, which in turn reports tothe application server 130, which in turn can initiate a process togenerate risk notifications which are provided to the user through theclient device 110.

Another type of user is a healthcare provider 112 who, again with thepatient's 111 express permission, also receives notifications regardinga patient's COPD management, as well as aggregated COPD community rescueevent data and derived statistics regarding COPD events and otherassociated data. Other types of users are also contemplated, such asparents/guardians of patients 111 who may also with to receivenotifications in the event that their own client devices 110 aredistinct from that of their children.

The client device 110 is a computer system, an example physicalimplementation which is described more completely with respect to FIG.2, below. The client device 110 is configured to wirelessly communicatewith the COPD analytics system 100 via network 150.With network 150access, the client device 110 transmits to system 100 the user'sgeographical location and the time of a controller or rescue medicationevent, as well as information describing the event as received from theassociated medicament device sensor 120 (referred to throughout as“sensor 120”).

Regarding user location and event times, the client device 110 maydetermine the geographical location and time of a rescue event throughuse of information about the cellular or wireless network 150 to whichit is connected. For example, the current geographical location of theclient device 110 may be determined by directly querying the softwarestack providing the network 150 connection. Alternatively, thegeographical location information may be obtained by pinging an externalweb service (not shown in FIG. 1) made accessible via network 150. Thetime of an event can be provided by the sensor 120 as part of the eventdata or added to event data by querying an appropriate software routineavailable as part of the client device's native operating system.

In addition to communicating with the application server 130, clientdevices 110 connected wirelessly to the COPD analytics system 100 mayalso exchange information with other connected client devices 110. Forexample, through a client software application 115, a healthcareprovider 112 may receive a risk exacerbation notification describing arecent rescue event about a patient 111, then in response send arecommendation to the patient 111 for post-COPD exacerbation treatment.Similarly, through application 115 patients 111 may communicate withtheir health care providers 112 and other patients 111.

Application 115 provides a user interface (herein referred to as a“dashboard”) that is displayed on a screen of the client device 110 andallows a user to input commands to control the operation of theapplication 115. The dashboard is the mechanism by which healthcareproviders 112 and patients 111 access the COPD analytics system 100. Forexample, the dashboard allows patients 111 and providers 112 to interactwith each other, receive COPD exacerbation risk notifications, exchangemessages about treatment, provide and receive additional event andnon-event data, and so on. Application 115 may be coded as a web page,series of web pages, or content otherwise coded to render within aninternet browser. Application 115 may also be coded as a proprietaryapplication configured to operate on the native operating system of theclient device 110. The dashboard is more completely described below inconjunction with FIG. 3.

In addition to providing the dashboard, application 115 may also performsome data processing on COPD rescue event data locally using theresources of client device 110 before sending the processed data throughthe network 150. Event data sent through the network 110 is received bythe application server 130 where it is analyzed and processed forstorage and retrieval in conjunction with database server 140. Theapplication server 130 may direct retrieval and storage request to thedatabase system 130 as required by the client application 115.

The client device 110 communicates with the sensor 120 using a networkadapter and either a wired or wireless communication protocol, anexample of which is the BLUETOOTH Low Energy (BTLE) protocol. BTLE is ashort-ranged, low-powered, protocol standard that transmits datawirelessly over radio links in short range wireless networks. After thesensor 120 and client device 110 have been paired with each other usinga BTLE passkey, the sensor 120 automatically synchronizes andcommunicate information relating to medicament device usage with theclient device 110. If the sensor 120 hasn't been paired with a clientdevice 110 prior to a rescue medication event, the information is storedlocally until such a pairing occurs. Upon pairing, the sensor 120communicates any stored event records to the client device 110. In otherimplementations, other types of wireless connections are used (e.g.,infrared or 802.11).

Although client devices 110 and medicament devices 160 are describedabove as being separate physical devices (such as smart phones andinhalers, respectively), in the future it is contemplated the medicamentdevices 160 may include not only sensors 120 integrated into a singlehousing with the device 160, but also aspects of the client device 110.For example, a medicament device 160 may include an audiovisualinterface including a display or other lighting elements as well asspeakers for presenting visual audible information. In such animplementation the medicament device 160 itself may present the contentsof notifications provided by the server 130 directly, in place of or inaddition to presenting them through the client devices 110.

I.B. Medicament Device and Sensor

The medicament device 160 is a medical device used to deliver medicationto the lungs of a user experiencing constricted respiratory airflow.Medicament devices .(e.g. inhalers) are typically portable and smallenough to be carried by hand for ease of accessibility when treatingrespiratory attacks. In one embodiment, medicine is delivered in aerosolform through a medicament device 160 such as a metered dose inhaler.Metered dose inhalers included a pressured propellant canister ofaerosol medicine, a metering valve for delivering a regulated medicinedosage amount, and a plastic holder that holds the pressurized canisterand also forms a mouthpiece for delivery of the medicine. In anotherembodiment, medicine is delivered in dry powder form through amedicament device 160 such as a dry powder inhaler. Dry powder inhalersmay have Cartesian ovular shaped bodies that house wheel and gearmechanisms enabling a user to index through a strip of dry powdermedication. The bodies of dry powder inhalers also include a manifoldand a mouthpiece to deliver dry powder to the user. Examples ofcontroller medications that are dispensed by a controller medicamentdevice 160 include beclomethasone, budesonide, and fluticasone as wellas combinations of those medications with a long-acting bronchodilatorsuch as salmeterol or formoterol. Examples of rescue medications thatare dispensed by a rescue medicament device 160 include albuterol,salbutamol, levalbuterol, metaproterenol, and terbutaline.

Each patient may be associated with more than one medicament device 160.For example, the patient may have a rescue medicament device 160 thatdispenses rescue medication, and a controller medicament device 160 thatdispenses controller medication. Similarly, each patient may beassociated with more than one sensor 120, each chosen to operate withone of the patient's medicament devices 160.

Generally, a sensor 120 is a physical device that monitors the usage ofthe medicament dispenser 160. The sensor 120 is either removablyattachable to the medicament dispenser without impeding the operation ofthe medication dispenser, or the sensor 120 is an integrated componentthat is a native part of the medicament dispenser 160 as made availableby its manufacturer.

The sensor 120 includes its own network adapter (not shown) thatcommunicates with the client device 110 either through a wiredconnection, or more typically through a wireless radio frequencyconnection. In one embodiment, the network adapter is a BLUETOOTH LowEnergy (BTLE) wireless transmitter, however in other embodiments othertypes of wireless communication may be used (e.g., infrared, 802.11).

The sensor 120 may also be configured to communicate more directly withthe application server 130. For example, if the network adapter of thesensor 120 is configured to communicate via a wireless standard such as802.11 or LTE, the adapter may exchange data with a wireless accesspoint such as a wireless router, which may in turn communicate with theapplication server 130 without necessarily involving the client device110 in every exchange of data. These two methods of communicating arenot mutually exclusive, and the sensor 120 may be configured tocommunicate with both the client device 110 and the application server130, for example using redundant transmission to ensure event dataarrives at the application server 130 or to provide information directlyto the client device 110 while the application server 130 is determiningwhat notification to provide in response to an event.

As introduced above, the sensor 120 captures data about usage of themedicament device 160. Specifically, each sensor 120 captures the timeand geographical location of either controller or rescue medicationevent, that is, usages of either the controller or rescue medicamentdevice 160, respectively, by the patient 111. Each sensor 120 transmitsthe event data in real-time or as soon as a network connection isachieved, automatically without input from the patient 111 or healthcare provider 112. The medication event information is sent to theapplication server 130 for use in analysis, generation of COPDexacerbation risk notifications, and in aggregate analyses of event dataacross multiple patients.

To accomplish this goal, there are a number of different ways for thesensor 120 to be constructed, and in part the construction will dependupon the construction of the medicament device itself 160. Generally,all sensors 120 will include an onboard processor, persistent memory,and the network adapter mentioned above that together function torecord, store, and report medication event information to the clientdevice 110 and/or server 130. Sensors 120 may also include a clock forrecording the time and date of events.

Regarding specific sensor 120 constructions, traditional inhalers, suchas mechanical dose counters, are not designed with sensors 120 in mind,and thus the sensor 120 may be constructed accordingly. Someimplementations in this manner include mechanical, electrical, oroptical sensors to detect movement of the device 160, priming of thedevice, activation of the device, inhalation by the user, etc. Incontrast, modern inhalers, such as deflectable membrane dose counters,include electrical circuitry may report event information as anelectrical data signal which a sensor 120 is designed to receive andinterpret, for example the medicament device 160 itself may reportmovement, priming, and activation to the sensor 120.

More information regarding hardware and software components for thesensors 120 and medicament devices 160, as well as the interactionbetween them to record one or both of controller and rescue medicationevents can be found in U.S. patent application Ser. No. 12/348,424,filed Jan. 1, 2009, and International Application No. PCT/US2014/039014,filed May 21, 2014, both of which are incorporated by reference hereinin their entirety.

I.C. Application Server

The application server 130 is a computer or network of computers.Although a simplified example is illustrated in FIG. 2, typically theapplication server will be a server class system that uses powerfulprocessors, large memory, and faster network components compared to atypical computing system used, for example, as a client device 110. Theserver typically has large secondary storage, for example, using a RAID(redundant array of independent disks) array and/or by establishing arelationship with an independent content delivery network (CDN)contracted to store, exchange and transmit data such as the COPDnotifications contemplated above. Additionally, the computing systemincludes an operating system, for example, a UNIX operating system,LINUX operating system, or a WINDOWS operating system. The operatingsystem manages the hardware and software resources of the applicationserver 130 and also provides various services, for example, processmanagement, input/output of data, management of peripheral devices, andso on. The operating system provides various functions for managingfiles stored on a device, for example, creating a new file, moving orcopying files, transferring files to a remote system, and so on.

The application server 130 includes a software architecture forsupporting access and use COPD analytics system 100 by many differentclient devices 110 through network 150, and thus at a high level can begenerally characterized as a cloud-based system. The application server130 generally provides a platform for patients 111 and healthcareproviders 112 to report data recorded by the sensors associated withtheir medicament devices 160 including both rescue medication andcontroller medication events, collaborate on COPD treatment plans,browse and obtain information relating to their condition and geographiclocation, and make use of a variety of other functions.

Generally, the application server 130 is designed to handle a widevariety of data. The application server 130 includes logical routinesthat perform a variety of functions including checking the validity ofthe incoming data, parsing and formatting the data if necessary, passingthe processed data to a database server 140 for storage, and confirmingthat the database server140 has been updated.

The application server 130 stores and manages data at least in part on apatient by patient basis. Towards this end, the application server 130creates a patient profile for each user. The patient profile is a set ofdata that characterizes a patient 111 of the COPD analytics system 100.The patient profile may include identify information about the patientsuch as age, gender, current rescue medication, current controllermedication, notification preferences, a controller medication adherenceplan, and a list of non-patient users authorized to access to thepatient profile. The profile may further specify a device identifier,such as a unique media access control (MAC) address identifying the oneor more client devices 110 or sensors 120 authorized to submit data(such as controller and rescue medication events) for the patient.

The profile may specify which different types of notifications areprovided to patients 111 and their personal healthcare providers 112, aswell as the frequency with which notifications are provided. Forexample, a patient 111 may authorize a healthcare provider 112 toreceive notifications indicating a rescue event or a change in thepatient's COPD control level. The patient 111 may also authorize theirhealthcare provider 112 be given access to their patient profile andrescue event history. If the healthcare provider 112 is provided accessto the patient profile of the patient 111, the healthcare provider mayspecify controller adherence or rescue medication plans. Medicationplans may include a prescribed number of doses per day for controllermedications.

The application server 130 also creates profiles for health careproviders 112. A health care provider profile may include identifyinginformation about the health care provider 112, such as the officelocation, qualifications and certifications, and so on. The health careprovider profile also includes information about their patientpopulation. The provider profile may include access to all of theprofiles of that provider's patients, as well as derived data from thoseprofiles such as aggregate demographic information, rescue andcontroller medication event patterns, and so on. This data may befurther subdivided according to any type of data stored in the patientprofiles, such as by geographic area (e.g., neighborhood, city) over bytime period (e.g., weekly, monthly, yearly).

The application server 130 receives rescue medication event informationfrom the client device 110 or the sensor 120, triggering a variety ofroutines on the application server 130. In the example implementationillustrated in FIGS. 4-6 below, the data analysis module 131 executesroutines to access COPD event data as well as other data including apatient's profile, analyze the data, and output the results of itsanalysis to both patients 111 and providers 112. This process isgenerally referred to as a COPD risk analysis.

The COPD risk analysis itself may include several different analyses.The exact analyses performed at any point in time or in response to anygiven rescue or controller medication event may vary either byimplementation, and/or based on the received event data, the particulardata already present in the patient's profile, or in response to changesin the COPD risk score in patient profiles connected directly to thepatient's profile or indirectly through a common health care provider.For example, several patients connected to a health provider mayexperience rescue or controller medication events triggering a COPD riskanalysis on a patient's profile that may not have any recent medicationevents. One such analysis determines the risk of a patient having anacute COPD exacerbation based on controller and rescue medication eventdata captured over several different sliding time windows extending backfrom the present. Generally, an acute exacerbation of COPD, also knownas acute exacerbations of chronic bronchitis (AECB), is a suddenworsening of COPD symptoms (shortness of breath, quantity and color ofphlegm) that typically lasts for several days.

Other analyses are also possible. For example, a risk analysis may beperformed on rescue and controller medication use for multiple patientsto identify based on spatial/temporal clusters (or outbreaks) ofmedication use based on historically significant permutations fromindividual, geographic, clinical, epidemiologic, demographic, or spatialor temporal baselines or predicted or expected values. Other types ofanalyses include daily/weekly adherence trends, adherence changes overtime, adherence comparisons to other relevant populations (e.g., allpatients, patients on a particular rescue medication or controllermedication or combination thereof, identification of triggers (spatial,temporal, environmental), rescue use trends over time, and rescue usecomparisons to other relevant populations.

Responsive to any analyses performed, the application server 130prepares and delivers push notifications to send to patients 111,authorized healthcare providers 112, and/or other users provided accessto the patient's profile. Notifications can provide details about thetiming, location, and affected patient(s) 111 involved in a medicationrescue event. Notifications may additionally comprise a distress oremergency signal that requests emergency assistance that are distributedto emergency assistance providers 112. Notifications may also includethe results of the COPD risk analysis performed by the data analysismodule 131.

In addition to providing push notifications in response to a COPD riskanalysis, notifications may also be provided as pull notifications, atparticular time intervals. Additionally, some notifications (whetherpush or pull) may be triggered not in response to a COPD risk analysisperformed in response to a rescue medication event, but instead inresponse to one of the underlying factors in the COPD risk analysischanging, such that an updated COPD risk analysis and subsequentnotification is warranted. For example, if weather conditions indicatethat an increase in air pollution is occurring or is imminent, this maytrigger the carrying out of COPD risk analyses for all patients locatedin the particular geographic area where the pollution is occurring.

Notifications are provided through the network 150 to clientapplications 115 in a data format specifically designed for use with theclient applications, and additionally or alternatively may be providedas short message service (SMS) messages, emails, phone calls, or inother data formats communicated using other communication mediums.

I.D. Database Server

The database server 140 stores data patient and provider data relateddata such as profiles, medication events, patient medical history (e.g.,electronic medical records). Patient and provider data is encrypted forsecurity and is at least password protected and otherwise secured tomeet all Health Insurance Portability and Accountability Act (HIPAA)requirements. Any analyses (e.g., COPD risk analyses) that incorporatedata from multiple patients (e.g., aggregate rescue medication eventdata) and are provided to users is de-identified so that personallyidentifying information is removed to protect patient privacy.

The database server 140 also stores non-patient data used in COPD riskanalyses. This data includes regional data about a number of geographicregions such as public spaces in residential or commercial zones wherepatients are physically located and may be exposed to pollutants. Thisdata may specifically include or be processed to obtain a patient'sproximity to green space (areas including concentrated numbers of treesand plants) and proximity to different types of human organizations suchas may be used to infer a patient's socioeconomic status. One example ofregional data includes georeferenced weather data, such as temperature,wind patterns, humidity, the air quality index, and so on. Anotherexample is georeferenced pollution data, including particulate countsfor various pollutants at an instance of time or measured empirically.The regional data includes information about the current weatherconditions for the time and place of the rescue event such astemperature, humidity, air quality index. All of the items of data abovemay vary over time, and as such the data itself may be indexed by time,for example separate data points may be available by time of day(including by minute or hour), or over longer periods such as by day,week, month, or season.

Although the database server 140 is illustrated in FIG. 1 as being anentity separate from the application server 130 the database server 140may alternatively be a hardware component that is part of another serversuch as server 130, such that the database server 140 is implemented asone or more persistent storage devices, with the software applicationlayer for interfacing with the stored data in the database is a part ofthat other server 130.

The database server 140 stores data according to defined databaseschemas. Typically, data storage schemas across different data sourcesvary significantly even when storing the same type of data includingcloud application event logs and log metrics, due to implementationdifferences in the underlying database structure. The database server140 may also store different types of data such as structured data,unstructured data, or semi-structured data. Data in the database server140 may be associated with users, groups of users, and/or entities. Thedatabase server 140 provides support for database queries in a querylanguage (e.g., SQL for relational databases, JSON NoSQL databases,etc.) for specifying instructions to manage database objects representedby the database server 140, read information from the database server140, or write to the database server 140.

I.E. Network

The network 150 represents the various wired and wireless communicationpathways between the client 110 devices, the sensor 120, the applicationserver 130, and the database server 140. Network 150 uses standardInternet communications technologies and/or protocols. Thus, the network150 can include links using technologies such as Ethernet, IEEE 802.11,integrated services digital network (ISDN), asynchronous transfer mode(ATM), etc. Similarly, the networking protocols used on the network 150can include the transmission control protocol/Internet protocol(TCP/IP), the hypertext transport protocol (HTTP), the simple mailtransfer protocol (SMTP), the file transfer protocol (FTP), etc. Thedata exchanged over the network 150 can be represented usingtechnologies and/or formats including the hypertext markup language(HTML), the extensible markup language (XML), etc. In addition, all orsome links can be encrypted using conventional encryption technologiessuch as the secure sockets layer (SSL), Secure HTTP (HTTPS) and/orvirtual private networks (VPNs). In another embodiment, the entities canuse custom and/or dedicated data communications technologies instead of,or in addition to, the ones described above.

II. Example Computing Devices

FIG. 2 is a high-level block diagram illustrating physical components ofan example computer 200 that may be used as part of a client device 110,application server 130, and/or database server 140 from FIG. 1,according to one embodiment. Illustrated is a chipset 210 coupled to atleast one processor 205. Coupled to the chipset 210 is volatile memory215, a network adapter 220, an input/output (I/O) device(s) 225, astorage device 230 representing a non-volatile memory, and a display235. In one embodiment, the functionality of the chipset 210 is providedby a memory controller 211 and an I/O controller 212. In anotherembodiment, the memory 215 is coupled directly to the processor 205instead of the chipset 210. In some embodiments, memory 215 includeshigh-speed random access memory (RAM), such as DRAM, SRAM, DDR RAM orother random access solid state memory devices.

The storage device 230 is any non-transitory computer-readable storagemedium, such as a hard drive, compact disk read-only memory (CD-ROM),DVD, or a solid-state memory device. The memory 215 holds instructionsand data used by the processor 205. The I/O device 225 may be a touchinput surface (capacitive or otherwise), a mouse, track ball, or othertype of pointing device, a keyboard, or another form of input device .The display 235 displays images and other information from for thecomputer 200. The network adapter 220 couples the computer 200 to thenetwork 150.

As is known in the art, a computer 200 can have different and/or othercomponents than those shown in FIG. 2. In addition, the computer 200 canlack certain illustrated components. In one embodiment, a computer 200acting as server 140 may lack a dedicated I/O device 225, and/or display218. Moreover, the storage device 230 can be local and/or remote fromthe computer 200 (such as embodied within a storage area network (SAN)),and, in one embodiment, the storage device 230 is not a CD-ROM device ora DVD device.

Generally, the exact physical components used in a client device 110will vary in size, power requirements, and performance from those usedin the application server 130 and the database server 140. For example,client devices 110, which will often be home computers, tabletcomputers, laptop computers, or smart phones, will include relativelysmall storage capacities and processing power, but will include inputdevices and displays. These components are suitable for user input ofdata and receipt, display, and interaction with notifications providedby the application server 130. In contrast, the application server 130may include many physically separate, locally networked computers eachhaving a significant amount of processing power for carrying out theCOPD risk analyses introduced above. In one embodiment, the processingpower of the application server 130 provided by a service such as AmazonWeb Services™. Also in contrast, the database server 140 may includemany, physically separate computers each having a significant amount ofpersistent storage capacity for storing the data associated with theapplication server.

As is known in the art, the computer 200 is adapted to execute computerprogram modules for providing functionality described herein. A modulecan be implemented in hardware, firmware, and/or software. In oneembodiment, program modules are stored on the storage device 230, loadedinto the memory 215, and executed by the processor 205.

III. Dashboard

The dashboard, for example dashboard 300 illustrated in FIG. 3A, allowsusers to interact with the COPD analytics system 100. The dashboard 300provides a means to transfer information on a user-to-user (e.g.,patient 111 to provider 112) or user-to-system/system-to-user basis.Dashboards 300 are accessed through the client application 115 on theclient device 110 and provide a mechanism for both patients andhealthcare providers to monitor medication rescue events, exchangepersonalized patient healthcare information, and receive notificationssuch as COPD exacerbation risk notifications. Patients may communicatewith other health care provider and other patients through the dashboard300, for example, to discuss and share information about COPD,medication usage, or COPD management. The ability to share COPDhealthcare information may give patients or healthcare care providersexperiencing a same issue a way to share individual perspectives.

The dashboard 300 also allows authorized health care providers 112 toaccess a list of patients to view, annotate, update, interact with, andexport information about COPD patient and community data and statisticsin various demographics or geographic segments. Using the dashboard 300,healthcare providers are able to monitor patients individually or inaggregate, to receive and provide feedback (e.g. compliance reminders)on how their associated patient populations are responding to COPDmanagement guidance. A healthcare provider who has access to individualor multiple patients has the ability to establish notificationthresholds, set parameters for the notifications, and receivenotifications when patients' event history matches certain conditions(e.g. rescue event). Additionally, the dashboard 300 can receive anddisplay regular reports of event patterns for specific demographicgenerated by the COPD analytics system 100.

The dashboard 300 presents a variety of information including tabulardata, graphical visualizations, and analyses to users through display“cards” 310. Display cards 310 are conformably suited to smallerdisplays typical of portable client devices 110, for example mobilephones or tablets, and include “bite size” pieces of information thatmimic the simplistic organizational style found in baseball cards. Thedashboard 300 may also include a system menu 305 that allows users tonavigate through different categories of healthcare information.

Notifications provided by the application server 130 are related to thedisplay cards 310. Generally, notifications include not only informationto be presented to the user through the application 115, but alsoparameters for specifying which display card 310 is to be used todisplay the contents of the notification. Generally, any informationpushed/pulled from the application server 130 may be associated with oneor more cards. For example, a notification can be pushed to the patientbased on the outcome of a COPD risk analysis. The dashboard 300 willprocess the notification and determine which card/s to use to presentthe information in the notification. Continuing the example, therecipient of the notification may make a request (pull) data from theapplication server 130. The application server 130 provides therequested data in another notification, and the dashboard 300 thendetermines which display card 310 to display the requested information.

To interact with information presented, some display cards 310 a includea input response 315 area. For example, in the display card 310 billustrated in FIG. 3B, a patient may scroll up or down in the inputresponse 315 area to select a controller medication used to manage COPDor select the “next” to move to an additional display card 310.

The dashboard 300 may provide a variety of different display cards 310,which may be organized into categories. An information card typeincludes cards that display data. Information cards may, for example,display medication rescue events, statistics, and maps including bothpatient data and community data. Information cards are furthersub-categorized into event trend, education, and alert display cards.

Event cards include data relating to rescue medication events, such as alist of historical medication rescue events for a specific patient, orpatient rescue event data overlaid on a geographical map for a specificprovider. For example, the display card 310 a illustrated in FIG. 3B isan event card that highlights patients experiencing COPD rescue eventsin a particular geographic area. The display card 310 q illustrated inFIG. 3I is an event card that displays an example medication usagereport. The example medication usage report includes a map of locationof a rescue usage event, environmental conditions at the location, andan input response area 315 for the recipient to add triggers for therescue usage event. Card 310 r illustrated in FIG. 3J displays rescuedevice usage for the previous week. The card displays a total number ofuses (14) and a number of uses for each day (14 for Monday and no usagefor each other day).

A trend card includes statistical information presented using a graph ora chart designed for clear comprehension by the recipient. FIG. 3Eillustrates two different example trend cards, plotting COPD rescueevents 310 c and COPD controller medication adherence 310 d, both overvarious time periods. FIG. 3Q illustrates four different example trendcards. Card 310 aa displays a time of day trend, card 310 bb displays asymptom trend, card 310 cc displays a day of week trend, and card 310 dddisplays a trigger trend.

An education card includes information meant to educate the recipient.FIGS. 3O and 3P illustrate education cards, providing general diseaseinformation 310 w and 310 x and providing tips for recipients 310 y and310 z. Education cards may include an input response 315 to allowrecipients to specify whether the information provided is relevant orinteresting for use in serving future cards.

Alert cards notify users of important information. Cards 310 o and 310 pof FIG. 3H are alert cards for informing a recipient that they are atrisk for an event 310 o and that data has not been received from adevice over a recent time period 310 p. FIG. 3R illustrates examplealert cards. Card 310 ee is similar to card 310 o and card 310 ff issimilar to card 310 p. Card 310 gg informs a recipient that a particulardose of medication has not been recorded by a device. Other alerts mayinclude an alert that a setting on the client device is preventingsyncing (e.g., BLUETOOTH is turned off) or that a patient's AsthmaControl Test score has changed.

A survey card type solicits a user response by presenting yes/no,multiple choice, or more open-ended questions for the user to respondto. For example, a healthcare provider or the COPD analytics system 100may send a survey card with a COPD questionnaire to a patient 111 todetermine a level of disease control for a specific patient. As anadditional example, a survey card may request the type of controllermedication that the patient 111 uses to treat COPD symptoms, as shown inthe display card 310b illustrated in FIG. 3B. Generally, survey cardsprovide the application server 130 with data that may be missing from apatient's medical history or patient profile (as introduced above),and/or provide an update to possible outdated information. Generally,one or more survey cards may be used to complete the patient enrollmentprocess and create a patient profile for storage in database server 140.As a specific example, when a patient 111 initially enrolls in the COPDanalytics system 100, a push notification will be triggered by theapplication server 130 prompting the patient 111 to create a patientprofile. Example of survey cards are illustrated in FIGS. 3F and 3G,which illustrates a survey question asking whether a patient has made anemergency room visits as a result of COPD exacerbations, what thepatient's controller medication is 310 f, how many times the patientused their rescue medication to control an event 310 g, and what theircontroller medication daily schedule is 310 h. Survey cards may also askabout a patients asthma triggers, such as whether pollen is a trigger310 e. Other survey cards ask a patient to rate their general quality oflife on 5-point Likert scale, to rate their quality of sleep, to ratetheir ability to be active over last 7 days, and so on. Other surveycards ask whether the patient feels better or worse than yesterday,whether the patient has had to go to emergency room or hospital in last12 months for an exacerbation and so on.

In some instances, patient behavior or sensor-reported event informationthat is inconsistent with existing patient information may trigger thesending of a survey card in order to resolve ambiguity as to thepatient's circumstances. For example, if the patient is experiencing agreater-than-expected count of COPD events, the survey card may requestinformation about the type of medication the patient is currently usingas listed on their medicament device 160, in order to verify that thecorrect medication is being used. As another example, if the reportedinformation about controller medication use indicates that the patientis only using the controller medication one time per day but theiradherence plan indicates they are supposed to be taking their controllermedication twice per day, system 100 could send a notification asking ifthe patient needs to change their adherence plan.

Navigation cards represent actionable data or messages that, upon userinteraction, may redirect the user to another screen or card that ispart of the dashboard 300. For example, if a patient wants to shareinformation or request specific medication plans for controllermedications with a physician, a navigation card would be used tofacilitate the sharing of information or enrollment in controlleradherence plan.

Additionally, navigation cards allow users to update informationsurrounding medication rescue events.

Adherence cards are designed to encourage a patient to continually usetheir controller medication on schedule over different periods of time.FIGS. 3C, 3D, and 3H illustrate example adherence cards. Cards 310 iillustrates an example of a “streak” or continuous run of on-timecontroller medication events, card 310 k illustrates better performancein aggregate even if no streak has been achieved, and card 310 lpresents improved patient health with respect to the number of asthma orCOPD symptom-free days experienced. Card 310 j is a survey card thatinquires as to the patient's physical state in response to recording asignificant number (e.g., two) rescue medication events within athreshold period of time of each other (e.g., 24 hours). Card 310 millustrates controller medication events as a graph, illustrating whenthe patient 111 did and did not take their controller medication on timeduring various periods during the day, as prescribed by their healthcare provider 112. Card 310 n illustrates a daily schedule forcontroller medication and an indicator for displaying whether thescheduled dose has been taken. In the example of card 310 n, theindicator is a red “X” indicating the scheduled dose has not been taken.A green check mark or another symbol could be used to indicate that thescheduled does has been taken.

Setup cards guide recipients in associating sensors with client devices110. FIG. 3N illustrates example setup cards for pairing a sensor to aclient device 110 using BLUETOOTH. Card 310 s prompts the recipient toinitiate the pairing process. Card 310 t prompts the user to select asensor device for pairing. Cards 310 u and 310 v notify the user thatthe sensor is paired.

FIGS. 3K, 3L, and 3M illustrate example user interfaces presented in thedashboard 300. FIG. 3K illustrates a list 320 of rescue usage events 322a-322 d. The list 320 may be presented to a recipient responsive toselection of the “View Timeline” input response area 315 c of FIG. 3J.Returning to FIG. 3K, the list 320 displays rescue usage events over atime period and includes details such as date, time, number of puffs,and location. Recipients may edit rescue usage events and/or addadditional details by selecting the edit interaction response areas 324a-d. FIG. 3L illustrates an example event summary 330 for a rescue usageevent. The event summary 330 may be provided responsive to a userselecting the edit interaction response areas 324 of FIG. 3K. Returningto FIG. 3L, The event summary 330 provides further details regarding arescue usage event. Recipients may edit the detail fields of the eventsummary 330 by selecting the interaction response areas 334 a-hcorresponding to each field. FIG. 3M illustrates a medication list 340.The list 340 includes medication information such as medication type(rescue, controller, etc.), dosage schedule, and sensors. Recipients mayinteract with the list 340 to add, edit, and delete medications andmedication information.

IV. Event-Driven Copd Risk Notifications

FIG. 4 shows an interaction diagram for providing COPD risknotifications based on medicament device monitoring, according to oneembodiment. As an initial step for generating COPD exacerbation risknotifications, a patient interfaces with the dashboard 300 to initialize405 a patient profile. Once the patient is finished completing theirpatient profile, the client device 110 transmits the patient profile foruse by the application server 130 and storage by the database server140. Once a patient's patient profile is initialized 405, theapplication server 130 may begin to receive rescue medications eventsdetected by the sensor 120 associated with the patient's medicamentdevice 160.

Referring now to FIG. 5, the application server 130 generally receives arescue event anytime the patient uses their rescue medicament dispenser160 to relieve difficulty breathing or other COPD symptoms. As anexample of the process for capturing such an event for a particulardevice 160/sensor 120 combination, at the start of symptoms, the sensor120 may detect 505 whether a medication dispenser 160 cover is opened.When the medication dispenser cover is opened, the sensor 120 may detectan acceleration 510 associated with a priming of the dispenser 160. Forsome types of medicament dispensers, the “priming” includes activating amechanism to release a dose of a medication from a packaging. In othertypes of medicament dispensers, the “priming” includes a rapid shakingof a medication canister.

After the priming action is detected, the sensor 120 is configured tostore 515 data associated with the rescue event in active memory of thesensor 120. The rescue event data may include information that describesthe time and date of associated with the rescue event, the status orcondition of the medicament device 160 (e.g. battery level), the numberof doses of medication remaining (before or after the event), self-testresults, and physiological data of a patient being treated with themedicament device 160 as measured by the sensor 120. As soon as thesensor establishes a network connection with either the client device110 or network 150, the sensor transmits 525 any locally stored rescueevent data to the client device 110 or the application server 130. Ifthe event data was transmitted to the client device 110 first, theclient device 110 then transmits 530 the rescue event data to theapplication server 130 as soon as the client device 110 establishes anetwork connection with the network 150. Depending upon theimplementation, either the client device 110 or sensor 120 will add thegeographic location where the event took place to the event datatransmitted to the application server 130.

Returning now to FIG. 4, upon receiving the receiving the medicationrescue event data, the application server 130 may request 415 furtherinformation from the patient describing the rescue medication event. Toobtain the information, the application server 130 generates a pushnotification, including the questions to be asked, to be sent to thepatient's client device 110. The client device 110 may present the pushnotification as a survey type card 310. The patient may respond to therequest 415 by providing inputs 315 in response to the survey card 310,their input providing the additionally requested information 420regarding the rescue event. The patient 111 may elect not to respond tothe request 415. This is permissible, any gaps in information may beobtained through later push notifications, or upon entry by provider 112after a meeting with the patient 111. In one implementation, the failureto receive the additionally requested data in response to request 415does not hold up the remainder of the analysis described in steps425-445.

Regarding the additional event data that is collected, the notificationmay specify 415, and the patient may provide 420, a list symptomsexperienced during the rescue event, triggers that may have initiatedthe event such as exposure to smoke or outdoor air pollutants, alocation of the rescue event , a label (e.g. work, home, school) for thelocation and a rating to signify the personal importance of the locationto the patient, and whether medication use was pre-emptive (e.g.,medication taken prior to exercising) in addition to any other relevantinformation. Card 310 j illustrated in FIG. 3C is an example of a cardthat may be used to obtain the additional information 415.

In addition to requesting additional event data, the application server130 accesses 425 stored regional data from the database server 140regarding the geographic location where the rescue event took place. Theapplication server 130 also accesses historical medication event datafor the patient 111. This historical medication event data can includeall of the data from any past controller or rescue medication event datafrom the patient's history over a variety of windows of time in thepast, and each historical event may include all of the same items ofinformation as was reported 410 for this event and collected 415/420upon follow up thereafter. Further, each historical event may have beenrecorded using the real time process described in this section inconjunction with FIGS. 4-6. Thus, the historical data relied upon doesnot necessarily rely upon, although it may use, data manually collectedor entered by a patient 111 or their health care provider 112, forexample by interviews during patient visits with the provider 112.

IV.A Rescue Medication Trend

The application server 130 performs a COPD risk analysis 430 todetermine changes in the patient's immediate condition, trends overtime, and future COPD exacerbation risk. Referring now to FIG. 6, thedata analysis module 131 receives 605 the rescue event data, historicalrescue event data, historical controller event data, regional data, andthe patient's profile. Using this historical data, the data analysismodule 131 calculates 610 a rescue medication baseline for the patient111 (or, simply, “baseline”). The baseline is used to determine whetherthe most recent medication event detected at step 410 has occurred moreor less than a mean/median/mode of rescue medication events over someprevious time window. Often the time window will start at the currenttime and date and extend backward in time, however in practice anyprevious window in time may be used.

The data analysis module 131 may calculate 610 the baseline according toany one variety of algorithms, one example of which is by summing eachrescue medication event over the time window (e.g., a day, a week, twoweeks, a month, longer) and dividing by the amount of time in the window(e.g., by the number of hours or days). In another example formula, thedata analysis module 131 calculates the baseline by summing each rescuemedication event over the preceding 29 days and dividing by the numberof days that were measured. As an example calculation, if the dataanalysis module 131 receives fifty rescue medication events over twentyfive individual days in the 29-day period, the calculated average valueof the baseline would be two.

If there is less data available than the length of the time period overwhich the mean/median/mode is calculated, for example due to a patientprofile having recently been created or rescue medications not havingbeing tracked during the time window, the baseline may instead becalculated based on the number of days-worth of data that are available.In one implementation, if the number of days of data available is belowa threshold (e.g., three), then the server 130 may decline to provide ananalysis on the basis that there is not enough data available toestablish a baseline, instead indicating that the server 130 is still ina learning period.

Although the baseline is described above as being determined withrespect to a time window, in an alternate implementation, it may bedetermined based on the amount of time that has passed since a fixednumber of rescue events have occurred, for example since the last 5events. This alternate calculation is functionally equivalent to thecalculation explained above, and can also provide a mean/median/moderepresentation of medication events for use in the COPD risk analysis.

The data analysis module 131 may also calculate a standard deviation forthe rescue medication events over the time window. In one example, thestandard deviation may be calculated according to:

$\begin{matrix}{s = \sqrt{\frac{1}{N - 1}{\sum\limits_{i = 1}^{N}\;\left( {x_{i} - \overset{\_}{x}} \right)^{2}}}} & {{Equation}\mspace{14mu} 1}\end{matrix}$

where s is the standard deviation, N is the number of days of data,x_(i) is the number of rescue events on the i-th day, and x-bar is theaverage number of daily rescue events over all measured days.

The data analysis module 131 compares 615 the baseline against rescuemedication events recorded over a more recent time window including therescue medication event detected at step 410 to determine a trend in thepatient's use of rescue medication (or “rescue medication trend”). Alsohere, the more recent time window generally extends backwards from thecurrent date and time, though this is not necessarily always the case.In one implementation, if the number of rescue medication events overthe more recent time window is below a threshold (e.g., four), then thedata analysis module 131 may decline to perform the comparison on thebasis that there is not enough data available to determine the rescuemedication trend.

The comparison of step 615 may yield a determination that the patient isor is not at risk of an imminent COPD exacerbation based on one or morerules. In one implementation, if a patient exceeds a threshold number ofrescue medication events during the more recent time window and thenumber of events exceeds the baseline for the more recent time window,the data analysis module 131 at least preliminarily labels the patientas being “at risk” for an imminent COPD exacerbation. For example, ifthe more recent time window is one day, and the threshold number ofrescue medication events is ten, if a patient experiences ten rescuemedication events during the day and the calculated baseline is lessthan ten, the data analysis module 131 at least preliminarily labels thepatient as being “at risk” for an imminent COPD exacerbation. The module131 stores this “at risk” rescue medication trend, and may further usethe rescue medication trend in determining the risk score, describedbelow.

Alternatively, if a patient does not experiences at least the thresholdnumber of rescue medication events during the more recent time window orthe number of events does not exceed the baseline for the more recenttime window, the data analysis module 131 at least preliminarily labelsthe patient as being “not at risk” for an imminent COPD exacerbation.Continuing with the example above, if the patient experiences fewer thanten rescue medication events and/or if the calculated baseline is ten orgreater, the data analysis module 131 at least preliminarily labels thepatient as being “not at risk” for an imminent COPD exacerbation. Themodule 131 stores this “not at risk” rescue medication trend, and mayfurther use the rescue medication trend in determining a risk score,described below.

The threshold number of rescue medication events may be a constant (e.g.10) and may be a default value or a value specified by a user (e.g., ahealthcare provider). Alternatively, the threshold number of rescuemedication events may be a function of the historical data, thebaseline, the standard deviation, or some combination thereof. In oneexample, the threshold, T, is given as:

T=B+αs   Equation 2

where B is the calculated baseline described above, α is a numericalcoefficient (example values, approximately 1.5), and s is the calculatedstandard deviation described above

Additionally or alternatively, the data analysis module 131 may analyzemore than one time window to determine a rescue medication trend. In oneimplementation, the data analysis module 131 examines two or more timewindows to determine if a patient's rescue medication use is increasingover time. The data analysis module 131 may determine whether a count ofrescue medication events of a more recent time window exceeds a count ofrescue medication events of a second time window preceding the morerecent time window. The data analysis module 131 may extend thiscomparison to any number of time windows, for example by determiningwhether a count of rescue medication events of the second time windowexceeds a count of rescue medication events of a third time window, andso on. In one example, each time window is 24 hours, and the dataanalysis module 131 examines three time windows. If a patientexperiences more rescue medication events in a more recent time windowthan a second time window that precedes the more recent time window, andmore rescue medication events in the second time window that precedes athird time window, the data analysis module 131 at least preliminarilylabels the patient as being “at risk” for an imminent COPD exacerbation,labels the patient as exhibiting a pattern of increasing rescuemedication use, or both. The module 131 stores this pattern label, andmay further use the pattern label to determine whether to label thepatient as being “at risk” for an imminent COPD exacerbation, describedbelow.

Determining that the patient exhibits a pattern of increasing rescuemedication use may be combined with additional criteria to determinewhether to label a patient as being “at risk” for an imminent COPDexacerbation. In one implementation, if a patient exhibits a pattern ofincreasing rescue medication use and the number of events for a morerecent time window exceeds a threshold as described above, the dataanalysis module 131 at least preliminarily labels the patient as being“at risk” for an imminent COPD exacerbation. For example, if a patientexhibits a pattern of increasing rescue medication use over a 3 dayperiod and the number of rescue events on the third day exceeds thethreshold as defined in Equation 2, the data analysis module 131 atleast preliminarily labels the patient as being “at risk” for animminent COPD exacerbation.

In one implementation, the rescue medication trend is determinative ofwhether or what kind of COPD notification to send. The COPD notificationis further described below with respect to FIG. 3H. In an alternativeimplementation, the rescue medication trend is one factor in a COPDexacerbation risk score (or simply “risk score”) that is determinativeof whether or what kind of COPD notification to send. Different users(e.g., patients and providers) may receive different COPD notifications.For example, providers may receive COPD notifications for any timeperiod as they are calculated while patients may only receive COPDnotifications from the preceding 24 hours. COPD notifications may belimited in other ways, such as limiting the number of COPD notificationsper day (e.g., one per day). An alternative method for determining arescue medication trend is described in U.S. Provisional Application62,242,095, filed Oct. 15, 2015, at Section IV.A (paragraphs[0073]-[0078]).

The above paragraphs of this section describe several differenttechniques for determining a rescue medication trend and determiningwhether a patient should be labeled as at risk of a COPD event. Thesetechniques are not mutually exclusive, and can be combined to providemultiple additive or alternative criteria for determining the rescuemedication trend and/or determining a patient's at risk label.

IV.B Risk Score

The risk score is a mathematical function or process flow taking intoaccount the rescue medication trend, and a controller medicationadherence. Often, these two inputs are weighted such the rescuemedication trend is more determinative of the risk score than thecontroller medication adherence, however this is not necessarily thecase.

The controller medication adherence represents the extent of thepatient's 111 adherence to taking their controller medication plan asprescribed by their health care provider 112, and as recorded ashistorical controller medication event data stored by the databaseserver 140. The controller medication adherence, is based on the numberof controller doses ingested by the patient 111 over some prior timewindow divided by the number of doses prescribed by the patient's healthcare provider 112 for that time window. In one embodiment, this timewindow is the previous week starting from the current day of the week.For example, if a patient is prescribed to take two doses of controllermedication a day, the patient is therefore prescribed a total offourteen doses for the week. If the patient has only taken seven dosesof controller medication, then the controller medication adherence wouldbe 50%. In other embodiments, other windows of time may be used todetermine controller medication adherence.

In one implementation, module 131 determines the risk score by adding 80points to the risk score if the patient's rescue medication trend is inthe category of “not at risk” and by adding 0 points if the patient'srescue medication trend is in the category of “at risk”. Module 131further adds 0 points to the risk score if the controller medicationadherence is less than 75%, and adds 20 points to the risk score if thecontroller medication adherence is between 75% to 100%.

If the application server 130 is not tracking the patient's controllermedication usage and thus the controller medication adherence is notavailable, the patient is given the benefit of the doubt, and 20 pointsare added to the risk score. This helps reduce the number of falsepositive notifications that are sent out indicating that the patient isat risk of a COPD exacerbation when in fact the controller medicationadherence was simply not available to be determined.

If the risk score is less than 79 points then the risk score indicatesthat 1) a rescue event has occurred 2) an increase in rescue medicationevents has occurred relative to the baseline and 3) that the patient isat a relatively “high” risk of COPD exacerbation. If the risk scorefalls between 80 and 99 points, the risk score indicates that 1) arescue event has occurred and 2) the patient is at a relatively“moderate” risk of COPD exacerbation. If the risk score is 100, the riskscore indicates that 1) a rescue event has occurred and 2) that thepatient is at a relatively “low” risk of COPD exacerbation.

IV.C Copd Risk Notifications

Returning to FIG. 4, the application server 130 provides 430 either therescue medication trend or the risk score as part of a notification tothe patient 111, their healthcare provider 112, and/or any otherauthorized users. The notification may include rescue medication trendor the risk score itself as a numerical value (e.g., the amount ofbaseline or a value between 0 and 100, respectively), the riskcategorization of either “at risk,” “not at risk,” “high,” “moderate,”or “low” risk of COPD exacerbation, as well as other information such asthe amount the patient is over the baseline and/or the number of rescuemedication events recorded by the system. FIG. 3H illustrates an exampleCOPD exacerbation notification. In this example, the categorizationprovided to the patient is that the patient is “at risk” (and thus, thisexample illustrates that the recue medication trend is being used), thatthey are 50% over the baseline, and that they have used their rescuemedication 10 times in the last 24 hours. Depending on whether therescue medication trend or the risk score is used, the notification mayor may not take into account controller medication use.

In addition to providing the COPD notification, the application server130 may also send additional notifications in response to a detectedrescue event 410. In one embodiment, such notifications includestatistical and graphical information describing the rescue event,presented using information type cards 310 for display 435 in thedashboards 300 on the client devices 110. An example of such a card isillustrated in FIG. 3E, card 310 c. The notifications may also includevarious permutations and combinations of time, location, temperature,humidity, and air quality index data regarding the geographic region inwhich the medication rescue event took place. This regional data may bepresented in cards 310 as graphs, charts, lists, etc. An example of sucha card is illustrated in FIG. 3B, card 310 a.

For example, a patient 111 may be provided a geographical map withpinpoints of all of their medication rescue event locations that haveoccurred in the last year. As another example, a patient 111 may beprovided with a geographical map include where event 410 took place,along with pinpoints of all medication rescue events that have occurredin the nearby geographical area either that day or within a thresholdperiod of time, to indicate recent patterns in medication rescue eventsfor that area. As another example, the healthcare provider 112 of thepatient 111 may be presented with medication rescue event data fromtheir patients 111 from that day or a recent period of time to help theprovider 112 identify medication rescue event trends.

V. Benefits

The COPD risk notifications provided to patients 111 and providers 112convey many benefits. Patients are informed of their risk of a COPDexacerbation and in real time or near real time (on the order of secondsto minutes), and can take action to prevent that occurrence, for exampleby improving their adherence to their controller medication, stayingaway from geographic areas with adverse conditions (e.g., pollution),adding or altering their prescribed medication regimen (such as anadjustment of dosage or the introduction of antibiotics or systemiccortiocsteroids), or scheduling an appointment with their doctor toaddress their recent spike in use of rescue medication which in turnwould reduce the frequency of emergency room and hospital visits for thepatient. Because the event data is automatically reported to theapplication server 130 without the need for patient input, the accuracyand quality of the event data is improved relative to manually-collecteddata by a health care provider 112 or other entity, and thus theaccuracy of the conclusion for the risk of COPD exacerbation is alsoimproved.

Additionally, follow up notifications provided by the application server130 including reports of nearby rescue medication events by otherpatients can provide patients with additional information about otherswho are suffering from similar issues and provide regional informationrelevant for the patient's decision-making. Follow up notifications canfurther encourage the user regarding progress on taking their adherencemedication. Ideally such notifications will prevent the occurrence ofCOPD exacerbations, thus preventing patient harm as well as hospitalvisits and their associated costs.

Health care providers informed of the risk of one or more of theirpatients' risk of COPD exacerbation can similar track the progress oftheir patients, and use the information to update their treatmentregimen for each patient, schedule appointments with patients, and soon. For patients at high risk of a COPD exacerbation, the notificationmay be a call to action for the health care provider to communicate withthe patient and encourage them to seek medical treatment . Follow upnotifications may provide information about regional effects (e.g.,pollution), patient controller medication adherence, etc.

VI. Additional Considerations

Although the discussion above focuses on COPD specifically, all systemsand processes described herein are equally applicable to chronicrespiratory disease (CRD) generally, and consequently can also be usedto assist in treatment of CRD as well as COPD.

It is to be understood that the figures and descriptions of the presentdisclosure have been simplified to illustrate elements that are relevantfor a clear understanding of the present disclosure, while eliminating,for the purpose of clarity, many other elements found in a typicalsystem. Those of ordinary skill in the art may recognize that otherelements and/or steps are desirable and/or required in implementing thepresent disclosure. However, because such elements and steps are wellknown in the art, and because they do not facilitate a betterunderstanding of the present disclosure, a discussion of such elementsand steps is not provided herein. The disclosure herein is directed toall such variations and modifications to such elements and methods knownto those skilled in the art.

Some portions of above description describe the embodiments in terms ofalgorithms and symbolic representations of operations on information.These algorithmic descriptions and representations are commonly used bythose skilled in the data processing arts to convey the substance oftheir work effectively to others skilled in the art. These operations,while described functionally, computationally, or logically, areunderstood to be implemented by computer programs or equivalentelectrical circuits, microcode, or the like. Furthermore, it has alsoproven convenient at times, to refer to these arrangements of operationsas modules, without loss of generality. The described operations andtheir associated modules may be embodied in software, firmware,hardware, or any combinations thereof.

As used herein any reference to “one embodiment” or “an embodiment”means that a particular element, feature, structure, or characteristicdescribed in connection with the embodiment is included in at least oneembodiment. The appearances of the phrase “in one embodiment” in variousplaces in the specification are not necessarily all referring to thesame embodiment.

As used herein, the terms “comprises,” “comprising,” “includes,”“including,” “has,” “having” or any other variation thereof, areintended to cover a non-exclusive inclusion. For example, a process,method, article, or apparatus that comprises a list of elements is notnecessarily limited to only those elements but may include otherelements not expressly listed or inherent to such process, method,article, or apparatus. Further, unless expressly stated to the contrary,“or” refers to an inclusive or and not to an exclusive or. For example,a condition A or B is satisfied by any one of the following: A is true(or present) and B is false (or not present), A is false (or notpresent) and B is true (or present), and both A and B are true (orpresent).

In addition, use of the “a” or “an” are employed to describe elementsand components of the embodiments herein. This is done merely forconvenience and to give a general sense of the invention. Thisdescription should be read to include one or at least one and thesingular also includes the plural unless it is obvious that it is meantotherwise.

While particular embodiments and applications have been illustrated anddescribed, it is to be understood that the disclosed embodiments are notlimited to the precise construction and components disclosed herein.Various modifications, changes and variations, which will be apparent tothose skilled in the art, may be made in the arrangement, operation anddetails of the method and apparatus disclosed herein without departingfrom the spirit and scope defined in the appended claims.

What is claimed is:
 1. A computer executed method comprising: receiving,over a first time window, at least one historical COPD rescue medicationevent from a client computing device associated with the patient;storing the rescue medication events in a database in association with apatient profile; receiving, over a second time window occurring later intime than the first time window, at least one current COPD rescuemedication event; and responsive to receiving the at least one currentCOPD rescue medication event, analyzing the historical COPD rescuemedication events, and the at least one current COPD rescue medicationevent together to determine a risk of a COPD exacerbation for thepatient; and sending a notification to the client computing deviceassociated with the patient, the notification comprising the risk of theCOPD exacerbation.